Simulated long-term effects of relugolix combination therapy on bone mineral density at the lumbar spine as predicted by a validated semi-mechanistic exposure-response model
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In both phase III trials SPIRIT-1 and SPIRIT-2, a similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences compared to placebo at 12 weeks in the relugolix CT arm.
“A similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences compared to the placebo at 12 weeks in the relugolix CT arm in both SPIRIT-1 and -2.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Relugolix CT enhanced daily functioning, as demonstrated by the EHP-30 pain score domain at week 24 (p < 0.0001 in both studies).
“Relugolix CT enhanced daily functioning, as demonstrated by the EHP-30 pain score domain at week 24 (p < 0.0001 in both studies)”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
These findings were statistically significant in SPIRIT-1 and -2 (p = 0.0149 and p = 0.0371, respectively).
“These findings were also statistically significant in SPIRIT-1 and -2 (p = 0.0149 and p = 0.0371, respectively).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Percentages of women showing a mean reduction in NRS scores of ≥2.8 points for dysmenorrhea and ≥2.1 points for non-menstrual pelvic pain at week 24 were 75.5% and 58.5% in the relugolix CT arm in SPIRIT-1, and 75.2% and 66% in the relugolix CT arm in SPIRIT-2.
“Percentages of women showing a mean reduction in NRS scores of ≥2.8 points for dysmenorrhea and ≥2.1 points for non-menstrual pelvic pain at week 24 were respectively 75.5% and 58.5% in the relugolix CT arm in SPIRIT-1, and 75.2% and 66% in the relugolix CT arm in SPIRIT-2.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Mean percentage BMD changes in the lumbar spine from baseline to week 24 in the relugolix CT and delayed relugolix CT arms were −0.70% and −1.99% in SPIRIT-1 and −0.78% and −1.92% in SPIRIT-2.
“Mean percentage BMD changes in the lumbar spine from baseline to week 24 in the relugolix CT and delayed relugolix CT arms were respectively −0.70 % and −1.99% in SPIRIT-1 and −0.78% and −1.92% in SPIRIT-2.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Relugolix CT is well tolerated, the incidence of vasomotor symptoms is similar to placebo, and BMD is maintained over 24 weeks.
“Relugolix CT is well tolerated, the incidence of vasomotor symptoms is similar to the placebo, and BMD is maintained over 24 weeks.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Response rates for dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of relugolix treatment.
“Response rates for dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of treatment.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Dysmenorrhea decreased rapidly from severe at baseline to mild by week 8 and was sustained through week 24 in 73% and 75% of women in SPIRIT-1 and -2, respectively.
“Dysmenorrhea decreased rapidly from severe at baseline to mild by week 8 and was sustained through to week 24 in 73% and 75% of women in SPIRIT-1 and -2, respectively.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Oral relugolix CT taken once daily significantly reduced dysmenorrhea and non-menstrual pelvic pain in women with endometriosis compared to placebo.
“In conclusion, oral relugolix CT taken once daily significantly reduced dysmenorrhea and non-menstrual pelvic pain in women with endometriosis compared to a placebo.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Relugolix CT yielded significant improvements in dyspareunia, with 40% and 46% reductions from baseline in NRS scores (mean change).
“Relugolix CT yielded significant improvements in dyspareunia, with 40% and 46% reductions from baseline in NRS scores (mean change).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
All results were statistically significant compared to placebo (p < 0.0001).
“All results were statistically significant compared to the placebo (p < 0.0001).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [120]
Cited by
Sorted by citations
Donnez, J., & Dolmans, M.-M. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10051085 · Cited by 182 · see citing works
Donnez, J., & Dolmans, M. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms222111342 · Cited by 49 · see citing works
“Results of phase III clinical trials investigating the effects of relugolix on endometriosis (SPIRIT-1 and 2) were recently published [56,57] (Table 1).”
BackgroundAdvances in targeting estrogen synthesis and receptors in patients with endometriosis
Clemenza, S., Vannuccini, S., Ruotolo, A., Capezzuoli, T., & Petraglia, F. (2022) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2022.2152325 · Cited by 34 · see citing works
“sis patients (SPIRIT-1 and 2) [67,68] showed a reduction of dysmenorrhea and non-menstrual pelvic pain compared to placebo.”
BackgroundMedical treatments of endometriosis: a review
Elbasueny, B., Geerts, M., Yang, E. C., Allaire, C., Yong, P. J., & Bedaiwy, M. A. (2022) · Reproductive and Developmental Medicine · doi:10.1097/rd9.0000000000000053 · Cited by 9 · see citing works
- Authors
- Zandvliet, A. S., Ouerdani, A., Lee, T.-Y., Migoya, E. M., Arjona Ferreira, J. C., & de Greef, R.
- Affiliations
- Myovant Sciences (United States) (US)
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2020-09
- Volume
- 114
- Issue
- 3
- Pages
- e350
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W3092775668
- Cited by
- 4
- References
- 0
- Citations by year
- 2022: 2 · 2021: 2
- FWCI
- 1.00
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (publishedVersion)
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Keywords
- relugolix, bone mineral density, lumbar spine, GnRH antagonist, exposure-response modeling, norethindrone acetate, combination therapy, long-term treatment, bone loss, estrogen replacement therapy
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